培养医师临床思维能力 提高对疾病的诊治水平

临床医学是一门实践科学、经验科学,要求临床医师在临床实践中逐渐认识疾病。合格的临床医师不但具有宽厚、扎实的基本理论知识,亦应具有较强的临床技能和思维能力。临床医师应学会并掌握正确、合理的临床思维路线、思维程序和思维方法 ,使自己对疾病的认识由感性认识逐步提高到理性认识,不断地丰富自己的临床经验。临床思维的目的是指导诊断与治疗,是诊治疾病的核心,可帮助临床医师更深刻地认识疾病规律。病例讨论是提高医师临床思维能力的必要环节。     

An Overview of the Adaptive Designs Accelerating Promising Trials Into Treatments (ADAPT-IT) Project

Randomized clinical trials, which aim to determine the efficacy and safety of drugs and medical devices, are a complex enterprise with myriad challenges, stakeholders, and traditions. Although the primary goal is scientific discovery, clinical trials must also fulfill regulatory, clinical, and ethical requirements. Innovations in clinical trials methodology have the potential to improve the quality of knowledge gained from trials, the protection of human subjects, and the efficiency of clinical research. Adaptive clinical trial methods represent a broad category of innovations intended to address a variety of long-standing challenges faced by investigators, such as sensitivity to previous assumptions and delayed identification of ineffective treatments. The implementation of adaptive clinical trial methods, however, requires greater planning and simulation compared with a more traditional design, along with more advanced administrative infrastructure for trial execution. The value of adaptive clinical trial methods in exploratory phase (phase 2) clinical research is generally well accepted, but the potential value and challenges of applying adaptive clinical trial methods in large confirmatory phase clinical trials are relatively unexplored, particularly in the academic setting. In the Adaptive Designs Accelerating Promising Trials Into Treatments (ADAPT-IT) project, a multidisciplinary team is studying how adaptive clinical trial methods could be implemented in planning actual confirmatory phase trials in an established, National Institutes of Health-funded clinical trials network. The overarching objectives of ADAPT-IT are to identify and quantitatively characterize the adaptive clinical trial methods of greatest potential value in confirmatory phase clinical trials and to elicit and understand the enthusiasms and concerns of key stakeholders that influence their willingness to try these innovative strategies.     

Clinical pathologist in Korea--training program and its roles in laboratories

A rapid development of practice of laboratory medicine in Korea owes its success to the clinical pathologists (CP), who have played a role of a pathfinder for laboratories. The Korean CP postgraduate education (residency) program is unique in that it is exclusively for laboratory medicine. The training program for clinical pathologists includes diagnostic hematology, diagnostic immunology, clinical microbiology, clinical chemistry, blood bank, diagnostic genetics, informatics and laboratory management. The program has produced a strong group of about 600 laboratory physicians, officially clinical pathologists since 1963. Most of Korean clinical pathologists work as laboratory directors, directors of university hospital laboratories or teaching faculty members in medical schools. The roles of clinical pathologists are laboratory management, interpretation of laboratory test results, clinical consulting services to clinicians and patients, ordering secondary tests after reviews of requested test results and utilization management. The clinical pathologists have developed clinical laboratories to be a main contributor for improved medical practice. During the last 40 years under the turbulent healthcare system, clinical pathologists have significantly contributed to safeguard the laboratory interests. The education program and the role of clinical pathologists are described.     

慢性重型肝炎临床与病理诊断不一致原因综合分析

目的分析慢性重型肝炎(CSH)临床与病理诊断不相一致的原因。方法根据血清生化指标与临床症状对患者做出临床诊断,再对慢性重型肝炎肝组织做病理诊断。结果慢性重型肝炎的临床与病理诊断符合率仅为14.58%。结论慢性重型肝炎的临床与病理诊断不一致,应建立完善的临床诊断标准。     

Enrolment of patients to clinical trials in haematological cancer in New South Wales: current status,perceived barriers and opportunities for improvement

Background: Enrolment of cancer patients in clinical trials is associated with significant positive outcomes. There are, however, limited Australian data on enrolment of patients with haematological malignancies to clinical trials. Aim: The aim of this study is to document the number of patients with haematological malignancies enrolled on clinical trials in NSW, to establish the barriers to trial recruitment and to examine possible means by which clinical trials participation may be improved. Methods: Quantitative data on clinical trial accrual were obtained from all sites participating in clinical trials in haematological malignancies in NSW from 2004 to 2007 and were compared with the cancer incidence data for that period. Qualitative data on barriers and strategies for improvement were gathered using semi‐structured interviews with clinical trials professionals from throughout NSW. Results: Between 2004 and 2007 there were significant increases in the number of active centres, clinical trials and trial participation, and by 2007, 10.5% of all eligible patients with haematological malignancies in NSW were enrolled in relevant clinical trials. Resource constraints were the greatest perceived barrier to participation, but the success of clinical trials is also challenged by difficulties associated with communication, ethics review, trial coordination, trial design and support for emerging centres. Conclusion: While participation in clinical trials in haematological cancer in NSW improved between 2004 and 2007, participation in clinical trials remains suboptimal. The development of specific strategies to address barriers to participation may facilitate increased enrolment and ultimately improve clinical outcomes in patients with haematological malignancies.     

Content and classification of clinical trials at a university hospital in Japan

"Standards on the Implementation of Clinical Trials on Drugs (New GCP)" is a Japanese government policy established in April 1998 with the aim of satisfying scientific and ethical requirements for industry-sponsored research, i.e., registration-directed clinical trials and clinical trials intended to support reexamination or reevaluation applications. Since then, efforts for more effective implementation of clinical trials have been promoted, including establishment of a system to invite more active participation of subjects in clinical trials and improvement of a network of medical institutions conducting clinical trials. These efforts should help to reactivate clinical trials in Japan, which reportedly have become stagnant. Although the New GCP addresses the quality of industry-sponsored clinical trials, investigators also construct study protocols without industry involvement. We reviewed clinical trials submitted by investigators at Gunma University Hospital to institutional review boards (IRBs) from June 1999 to February 2002. Ten clinical research coordinators contributed to the present survey. A total of 151 investigator-initiated clinical trials reviewed included a wide variety of content; and investigators from many institutions and organizations conducted trials. Most of the ethical guidelines for approving proposed trials represented the provisions of the Declaration of Helsinki. However, additional guidelines prepared by the Japanese Ministry of Health, Labour and Welfare were also helpful. Development of a support system for clinical trails requires the contribution of clinical research coordinators. Flexible management and careful attention to both the protocol and its execution by the investigators were also important for promoting clinical trials on the basis of meticulous patient care.     

Clinical excellence in cardiology

A recent study identified 7 domains of clinical excellence on the basis of interviews with "clinically excellent" physicians at academic institutions in the United States: (1) communication and interpersonal skills, (2) professionalism and humanism, (3) diagnostic acumen, (4) skillful negotiation of the health care system, (5) knowledge, (6) taking a scholarly approach to clinical practice, and (7) having passion for clinical medicine. What constitutes clinical excellence in cardiology has not previously been defined. The author discusses clinical excellence in cardiology using the framework of these 7 domains and also considers the additional domain of clinical experience. Specific aspects of the domains of clinical excellence that are of greatest relevance to cardiology are highlighted. In conclusion, this discussion characterizes what constitutes clinical excellence in cardiology and should stimulate additional discussion of the topic and an examination of how the domains of clinical excellence in cardiology are related to specific patient outcomes.     

Setting up a respiratory trials unit

Clinical trials are essential in advancing our knowledge and treatment of patients with respiratory disease. Conducting well-designed clinical studies which accurately and reliably answer important clinical questions is challenging. The expertise required to deliver such studies is increasingly concentrated in clinical trials units. This article will describe some of the challenges associated with clinical studies and the methods and personnel involved in a clinical trials unit.     

Diagnosis of obstructive sleep apnea in adults

The diagnosis of obstructive sleep apnea syndrome (OSAS) requires the combined assessment of relevant clinical features and the objective demonstration of abnormal breathing during sleep, and current evidence indicates that attempts to base the diagnosis of the clinical syndrome on either aspect alone are unreliable. The present review discusses the clinical assessment of patients with suspected OSAS and also the potential added value of structured questionnaires and clinical prediction models that seek to improve the diagnostic value of clinical assessment from the formalized evaluation of selected clinical features. While the traditional "gold standard" for objective assessment is laboratory-based polysomnography, there is growing evidence that limited sleep studies focused on respiratory and cardiac variables are adequate in most cases, and are particularly suited to home-based assessment. The choice between home versus sleep laboratory studies should be decided by taking into account resource limitations and the clinical index of suspicion for OSAS. At present, patients with either a low or high clinical index of suspicion for OSAS appear most suited to home-based investigation, whereas those with intermediate levels of clinical suspicion, or who present with atypical clinical features, may best be assessed by full polysomnographic studies in the first instance.     

胃食管反流病的中医药应用进展

胃食管反流病（GERD）是临床常见病、多发病,临床症状复杂,易复发,逐渐受到临床重视。中医药治疗GERD具有改善临床症状、降低复发率、提高生活质量等优势,临床疗效良好。本文从GERD的中医病因病机、中医药治疗进展、中医药作用机制三方面进行归纳,以为临床诊治提供些许借鉴和参考。     

Determining the efficacy of antiplatelet therapies for the individual: lessons from clinical trials

This article focuses on lessons learned from clinical trials of antiplatelet therapies-in particular, that the degree of inhibition of ex vivo platelet aggregation does not necessarily directly translate into clinical efficacy. As an example, the case of the oral platelet glycoprotein IIb/IIIa inhibitors is presented, in which despite consistent evidence of substantial inhibition of platelet aggregation, this class of drugs provided no clinical benefit in Phase III trials and, in fact, was harmful. Several hypotheses for these unexpected findings have been proposed, but none has been confirmed. The connection between ex vivo inhibition of platelet aggregation and clinical benefit of platelet P2Y(12) antagonists is also not straightforward and is currently being tested in large clinical trials. A link between inflammatory status and clinical benefit from antiplatelet agents continues to emerge and highlights the fact that biomarkers beyond ex vivo platelet aggregation may predict the clinical benefit of antiplatelet agents that can reduce platelet activation (i.e., aspirin and thienopyridines). Results of past and ongoing trials hold valuable clues to determining the appropriate targets for maximizing antiplatelet efficacy, but the current lack of a proven ex vivo assay that correlates with clinical outcomes hampers clinical investigation, drug development programs, and clinical practice.     

中轴型脊柱关节炎患者临床达标和影像学缓解的现状调查及影响因素分析

目的 调查中轴型脊柱关节炎（axSpA）患者临床达标和影像学缓解的现状并分析其影响因素。方法 根据既往治疗方案、基于C反应蛋白（CRP）计算的强直性脊柱炎疾病活动度评分（ASDAScrp）及加拿大脊柱关节炎研究协会（SPARCC）评分，分别对233例axSpA患者进行分组并比较其临床资料。采用多因素logistic回归分析评估axSpA患者临床达标和影像学缓解的影响因素。结果 axSpA患者临床达标率为25.3%，临床达标组影像学未缓解率（32.2%）低于临床未达标组（56.3%，P<0.05）。临床达标组CRP低于临床未达标组，接受抗肿瘤坏死因子（TNF）-α治疗患者比例高于临床未达标组（P<0.05）。影像学缓解组ASDAScrp低于影像学未缓解组，接受抗TNF-α治疗患者比例高于影像学未缓解组（P<0.05）。未正规治疗组患者临床达标率和影像学缓解率均低于抗TNF-α治疗组（P<0.05）。多因素logistic回归分析结果显示，CRP升高是axSpA患者临床未达标的危险因素（P<0.001）；ASDAScrp升高是axSpA患者影像学未缓解的危险因素（P<0.05）；抗TNF-α治疗既是axSpA患者临床达标也是其影像学缓解的保护因素（P<0.05）。结论axSpA患者的治疗达标率仍偏低。CRP和ASDAScrp升高分别为axSpA临床未达标和影像未学缓解的危险因素，而抗TNF-α治疗可促进其临床达标和影像学缓解。     

Update of the economic analyses of the use of the colony-stimulating factors

The colony-stimulating factors have been used effectively in a variety of clinical settings to prevent febrile neutropenia and to assist patients receiving dose-intensive chemotherapy with or without stem cell support. Several studies have confirmed the clinical efficacy of the colony-stimulating factors used prophylactically in both solid tumors and the hematologic malignancies. The cost of these agents, along with their large scale clinical use, has prompted a number of economic investigations. Economic analyses based on measures of resource utilization derived from randomized clinical trials have provided febrile neutropenia risk threshold estimates for the cost saving use of prophylactic colony-stimulating factor. A number of important studies concerning the clinical and economic impact of these agents have been reported over the past year. These include a revised cost minimization study based on improved febrile neutropenia cost information and a cost-effectiveness analysis in the adjuvant breast cancer setting based on a clinical prediction model to select patients at high risk for neutropenic complications. Continuing clinical and economic evaluation along with updating of clinical practice guidelines is needed due to rapid technologic and clinical advances in this area.     

How to design a clinical in cardiology. The main issues.

Accumulated clinical experience, arising from consecutive observation of patients, produces biased evaluations of drug efficacy. Only properly designed clinical trials can minimize bias and evaluate drug efficacy. However, clinical experience can be useful in clinical trial planning. The authors review the main aspects of the methodology of clinical trials in cardiology, namely the different phases of clinical research in humans, definition of the population, how to avoid bias, design and randomization options, determination of sample size, outcome types, and precautions to be taken during follow-up.     

New directions in clinical outcomes assessment

In recent years, electrophysiology clinical research has made tremendous progress. Not only have the standards for conducting research and assessing clinical outcomes improved substantially, but the power of well-conducted and designed randomized clinical trials has been realized. This has led to the emergence of a plethora of randomized clinical trials in electrophysiology. Despite these improvements, there is an immense need to explore and develop better approaches for assessing clinical outcomes. In this article, I review the strengths, challenges, and limitations of randomized clinical trials, especially as they relate to the field of electrophysiology. To address some of these challenges, I propose potential solutions that involve enhancing clinical trials and complementing them with large registries and databases of electronic medical records. If prudently developed and executed, these new directions in assessing clinical outcomes have great potential to inform, and thereby improve the care of patients receiving electrophysiologic interventions.     

Should contemporary rheumatoid arthritis clinical trials be more like standard patient care and vice versa?

The information used by rheumatologists when delivering care to patients with rheumatoid arthritis (RA) is derived mainly from two sources: randomised controlled clinical trials and experience in clinical care. However, these two sources differ significantly because (a) the extensive inclusion and exclusion criteria result in clinical trial participants being recruited from only a minority of patients seen in standard clinical care; (b) assessments in clinical trials are conducted according to standard quantitative measures and indices, while standard clinical care of most patients with RA is generally conducted empirically, without collection of any quantitative data other than laboratory tests to estimate prognosis and document change in status; and (c) although baseline databases of various clinical trials (and observational studies) are 60-90% identical in content, they are not standardised and therefore not amenable to direct comparisons. Strategies to promote similarities between clinical trials and standard clinical care in patients with RA may include: more generalised inclusion criteria; incorporation of quantitative measurement into standard care, easily accomplished by asking each patient to complete a simple questionnaire at each visit to a rheumatologist; and consensus among rheumatologists for databases with standard content and format in clinical care and research involving patients with RA.     

社区获得性肺炎临床路径实施效果的评价与分析

目的 了解社区获得性肺炎临床路径的实施情况,分析我院临床路径实施的效果.方法 回顾性分析我院2011年11月～2012年8月收治的253例成人社区获得性肺炎患者的临床资料,了解入径率、路径组与非路径组平均住院日、路径组抗生素使用、CURB-65评分对临床路径的价值以及未进入临床路径的原因.结果 入径率为81.0％;路径组平均住院日为（10.46±4.36）天,非路径组平均住院日为（22.31±12.53）天;路径组抗生素使用基本符合指南要求;CURB-65评分越低,越有可能进入临床路径;未能进入临床路径的原因有病情加重转入ICU,合并肺癌、肾功能衰竭、泌尿系感染、脑血管病等基础疾病、住院时间过长、使用了指南之外的抗生素、因经费问题要求出院等.结论 实施社区获得性肺炎临床路径能缩短平均住院日,促进抗生素使用规范,减少平均住院费用,有利于促进医院整体医疗安全、质量、效率及费用控制等综合管理水平的提高.     

Evaluation of clinical pharmacist's interventions in an infectious diseases ward and impact on patient's direct medication cost

BackgroundA clinical pharmacist is a key member of the antimicrobial multidisciplinary team involved in patients' pharmacotherapy monitoring. The aim of this study was to determine the frequency and type of medication errors, the type of clinical pharmacy interventions, acceptance of pharmacist interventions by health-care provider team, nursing staff satisfaction with clinical pharmacy services, and the probable impact of clinical pharmacy interventions on decreasing direct medication costs at an infectious diseases ward in Iran.MethodsAll clinical pharmacist interventions such as preventing medication errors were recorded in a previously designed pharmacotherapy monitoring forms. Direct medication cost of patients admitted during the study period was compared with that of subjects hospitalized at the same ward during the year before the intervention period to determine the impact of clinical pharmacy interventions on direct medication costs.ResultsThe 3 most frequent medication error types were incorrect dose (35.5%), omission error (24.3%), and incorrect medication (14.3%). The mean number of clinical pharmacist intervention per patient was 3.2. Forty percent of clinical pharmacists' interventions are moderate to major clinical significant. Thirty nine percent of clinical pharmacist's interventions had moderate to major financial benefits in present study. The direct medication cost per patient was decreased about 3.8% following clinical pharmacist's interventions.ConclusionOur data demonstrated that incorrect dose was the most frequent medication error in the infectious diseases ward. Major portion of clinical pharmacist interventions were accepted by physicians and nursing staff. Clinical pharmacist interventions non-significantly decreased the direct medication cost of patients.